A Clinical trial to Breast Cancer where two different ways to give the chemotherapy capsules are compared

A Randomised phase II study with the combination of Xeloda (Capecitabine) plus Navelbine Oral ( Vinorelbine) day 1 and day 8 every 3. week versus Xeloda plus Navelbine Oral given metronimic as 1. or 2. line chemotherapy to patients with HER2 negative local metastatic breastcancer. - XeNa

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003564-72-DK

Enrollment

110

Registered

2012-01-13

Start date

2012-01-13

Completion date

Unknown

Last updated

2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient with relapse of breast cancer will be randomised for two different chemotherapy regimes ( 2 treatments arms)

Interventions

Trade Name: Navelbine Product Name: Navelbine Product Code: L01CA Pharmaceutical Form: Capsule

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with relaps of breastcancer with WHO performance status equal to or under 2. Life time more than 16 weeks. age 18 years and older. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Earlier treatment with Navelbine or Xeloda. Patients not able to swallow tablets. CNS metastases. Insufficient bone marrow or liver funktion.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effect of an experimental chemotherapy arm, where Navelbine is given together with Xeloda in a metronomic manner to a standard treatment arm of Navelbine and Xeloda. We expect that the experimental arm is better than the standard treatment arm;Secondary Objective: To compare the toxicity and time to progression and overall survival of the two treatment arms.;Primary end point(s): To determine the response rate in the two treatment arms. ;Timepoint(s) of evaluation of this end point: Response after 3 cycles of chemotherapy will be evaluated	—

Measure

Time frame

Main Objective: To compare the effect of an experimental chemotherapy arm, where Navelbine is given together with Xeloda in a metronomic manner to a standard treatment arm of Navelbine and Xeloda. We expect that the experimental arm is better than the standard treatment arm;Secondary Objective: To compare the toxicity and time to progression and overall survival of the two treatment arms.;Primary end point(s): To determine the response rate in the two treatment arms. ;Timepoint(s) of evaluation of this end point: Response after 3 cycles of chemotherapy will be evaluated

—

Secondary

Measure	Time frame
Secondary end point(s): Time to progression and overall survival;Timepoint(s) of evaluation of this end point: Patients will be followed to death of dissease.	—

Countries

Denmark

Contacts

Public ContactClinical Trial Unit

Aarhus University Hospital

svelan@rm.dk004589494440

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026